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Architect

FDA UDI

Class II (US FDA UDI)

by Abbott Laboratories, Inc.

Identity

Trade Name
ARCHITECT FDA UDI
Generic Name
Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay FDA UDI
Device Name
ARCHITECT ROMA FDA UDI
Model / Reference
6P30-21 FDA UDI
Description
ARCHITECT ROMA FDA UDI

Identifiers

Catalog Number
06P3021 FDA UDI
Primary DI / UDI-DI
00380740138738 FDA UDI
FDA Product Code
ONX FDA UDI
GMDN Term
Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassay FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.6050 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Cancer antigen 125 (CA125) IVD, kit, chemiluminescent immunoassayHuman epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay

Architect by Abbott Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Abbott Laboratories, Inc.

Sources (1)

  • FDA UDI 378924fb-677e-4f84-a777-75fc49d17b3e 35 fields · synced May 30, 2026